A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients with Heart Failure (CONFIRMATION-HF)

NCT06024746 | Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 202303CPC
• Study Type: interventional
• Target: 1,500
• Locations: 3 countries
• Sites: 15

Brief Summary

Combination therapy of finerenone plus empagliflozin will be compared to usual care to determine the efficacy and safety of treatment in patients hospitalized with heart failure.

Conditions

Heart Failure

Keywords

Heart Failure; Hospitalized

Outcome Measures

Primary Outcomes (3)

• Clinical benefit

  Hierarchical composite of the following: * Time to all-cause mortality * Number of total HF events * Time to first HF event * Difference of 5 points or greater on the Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS) assessed by the win-ratio method

  6 months

• Number of serious adverse events (AEs).

  \- Serious AEs (excluding efficacy endpoints).

  6 months

• Number of adverse events leading to discontinuation of study drug.

  \- AEs leading to discontinuation of finerenone or empagliflozin.

  6 months

Secondary Outcomes (3)

• Time to first death from any cause or HF event.

  6 months

• Mean change from baseline to 6 months in the Total Symptom Score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS).

  6 months

• Number of HF events from baseline to Day 90.

  90 days

Study Arms (2)

Finerenone plus empagliflozin

EXPERIMENTAL

Drug: Finerenone; Drug: Empagliflozin

Usual care

NO INTERVENTION

Usual care management

Interventions

Finerenone DRUG

Oral finerenone.

Finerenone plus empagliflozin

Empagliflozin DRUG

Oral empagliflozin.

Finerenone plus empagliflozin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide electronic or written informed consent, either personally or through a legally authorized representative, as permitted by local regulations
• Age ≥18 years or legal age of majority if \>18 years in the participant's country of residence
• Current hospitalization or recently discharged with the primary diagnosis of heart failure
• Heart failure signs and symptoms at the time of hospital admission
• Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ≥500 pg/mL or B-type natriuretic peptide (BNP) ≥125 pg/mL according to the local lab for patients in sinus rhythm; or elevated NTproBNP ≥1500 pg/mL or BNP ≥375 pg/mL for patients with atrial fibrillation (AF), measured during the current hospitalization or in the 72 hours prior to hospital admission
• Fulfillment of protocol defined stabilization criteria (if randomized during hospitalization)
• Treatment during the index hospitalization with at least 1 intravenous dose of a loop diuretic (e.g., furosemide, torsemide, bumetanide).
• Negative pregnancy test and agreement to use adequate contraception during trial (female participants only)

You may not qualify if:

• Diagnosis of type 1 diabetes or prior history of diabetic ketoacidosis
• Documented prior history of severe hyperkalemia in the setting of MRA use
• Treatment with non-steroidal mineralocorticoid receptor antagonist (MRA) or SGLT2i
• Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m² and/or potassium \>5.0 mmol/L
• Acute myocardial infarction, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days
• Prior or planned heart transplant
• Hemodynamically significant uncorrected primary cardiac valvular disease as primary cause of heart failure
• Cardiomyopathy due to acute inflammatory heart disease, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, known hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or pericardial constriction
• Probable alternative cause of participant's heart failure symptoms
• Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or moderate CYP3A4 inducers, or potent CYP3A4 inducers
• Known hypersensitivity to the IP (active substance or excipients)
• Any other condition or therapy which would make the patient unsuitable for this study

Sponsors & Collaborators

• Colorado Prevention Center: lead
• Saint Luke's Mid America Heart Institute: collaborator
• Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma: collaborator

Study Sites (15)

CON-10004 Fairhope, AL Investigational Site

Fairhope, Alabama, 36532, United States

RECRUITING

CON-10075 El Centro, CA Investigational Site

El Centro, California, 92243, United States

RECRUITING

CON-10024 Sacramento, CA Investigational Site

Sacramento, California, 95816, United States

RECRUITING

CON-10022 Atlanta, GA Investigational Site

Atlanta, Georgia, 30303, United States

RECRUITING

CON-10030 Baton Rouge, LA Investigational Site

Baton Rouge, Louisiana, 70808, United States

RECRUITING

CON-10002 Kansas City, MO Investigative Site

Kansas City, Missouri, 64111, United States

RECRUITING

CON-10045 Amarillo, TX Investigational Site

Amarillo, Texas, 79106, United States

RECRUITING

CON-10015 Austin, TX Investigational Site

Austin, Texas, 78705, United States

RECRUITING

CON-21003 Goiania, Goias Investigational Site

Goiânia, Goiás, 74453-200, Brazil

RECRUITING

CON-21007 Joinville, Santa Catarina Investigational Site

Joinville, Santa Catarina, 89200-000, Brazil

RECRUITING

CON-21004 Braganca Paulista, Sao Paulo Investigational Site

Bragança Paulista, São Paulo, 12916542, Brazil

RECRUITING

CON-21049 Sao Paulo, Sao Paulo Investigational Site

São Paulo, São Paulo, 05652-900, Brazil

RECRUITING

CON-11012 Surry, BC Investigational Site

Surrey, British Columbia, V3V OC6, Canada

RECRUITING

CON-11007 North York, ON Investigational Site

North York, Ontario, M6B 3H7, Canada

RECRUITING

CON-11005 Sherbrooke, QC Investigational Site

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

finerenone; empagliflozin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Marc Bonaca

CONTACT

(303) 860-9900; info@cpcmed.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: September 6, 2023
• Study Start: July 9, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3); BR (4); US (8)